Traditionally, to achieve FDA 21 CFR Part 820 compliance, you would labor through mountains of paper documents and disparate digital information, or invest in costly Document Management Systems. With Polarion you can create a Document History File (DHS) – including forensic level traceability – in minutes, and satisfy any audit.

How to Achieve FDA 21 Part 820 Compliance with Polarion

Our customers have recently discovered that using Polarion software for FDA 21 Part 820 compliance allows for utilizing smaller teams and deliver quicker results, with cost savings of between 35% to 50%.

See how you can accelerate innovation while ensuring quality and compliance

One of our Polarion experts will give you a one-on-one guided tour of the pioneering application lifecycle management software that is currently used by more than 10,000 firms worldwide to create better complex software, faster.